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Recruiting NCT06976034

oCular Examination at Cell RESolution With Optical TransmissionTomography

No phase Interventional Glaucoma Associated With Other Ocular Disorders

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Optical Transmission Tomography (OTT), Optical Coherence Tomography (OCT), Specular Microscopy (SM).
Who it may be relevant to
Registry conditions: Glaucoma Associated With Other Ocular Disorders. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

Understanding the pathogenesis of eye diseases has benefited greatly from recent advances in ophthalmic imaging. However, current clinical imaging systems, such as optical coherence tomography (OCT), are limited in terms of resolution, acquisition speed or access to certain eye functions. Our team has participated in the development of a new generation of imaging technology known as optical transmission tomography (OTT), which enables imaging of the anterior parts of the eye with high cellular resolution, a wide field of view and reduced examination delay.

Detailed description

For healthy subjects: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out twice, at an interval of two (2) years (inclusion visit + visit at 24 months). Several imaging images will be taken by two different operators during these sessions.

For patients: an imaging examination using each system (OTT + OCT + specular microscopy) will be carried out by two different operators, and several imaging images will be taken. These examinations will be carried out at the inclusion visit and at the following visits according to the disease assessment schedule, lasting up to a maximum of 4 years.

Interventions

  • Device Optical Transmission Tomography (OTT)
    Multiple imaging sessions added by research using the systems described (OTT) will be carried out by two different operators at different positions during these sessions.
  • Device Optical Coherence Tomography (OCT)
    Multiple imaging sessions (OCT) already used in standard of care will be performed by two different operators at different positions during these sessions.
  • Device Specular Microscopy (SM)
    Multiple imaging sessions (SM) already used in standard of care will be performed by two different operators at different positions during these sessions.

Primary outcome measures

  • Image quality [Time frame: between 1 day and 4 years]
  • Endothelial cell density [Time frame: between 1 day and 4 years]
  • Imaging new corneal and lens structures [Time frame: between 1 day and 4 years]

Eligibility criteria

Inclusion criteria

For Patients:

  • 200 subjects aged 18 to 80 years;
  • Male or female;
  • with an ocular disease affecting the cornea, ocular surface, lens (cataract) or glaucoma, or requiring refractive surgery or post-refractive surgery follow-up;
  • Are covered by the French Assurance Maladie;
  • Have signed an express, free and informed consent form.

For Healthy volunteers:

  • 100 subjects aged 18 to 80 years;
  • Male or female;
  • Healthy subjects with no known pathology directly or indirectly affecting ocular structures;
  • Covered by the French Assurance Maladie.
  • Having signed an express, free and informed consent form.

Exclusion criteria

For all participants:

  • Inability to hold a still position on a standard ophthalmic chin rest;
  • Conjunctivitis or other contagious contact disease in active phase;
  • Having an implanted pacemaker or other electronic medical device;
  • Having a predisposition to iridocorneal angle closure;
  • Vulnerable persons or persons under legal protection (pregnant or breast-feeding women; persons under guardianship,

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

France · 1 center
  • Centre Hospitalier National d'Ophtalmologie des Quinze-Vingts — Paris

Identifiers

NCT: NCT06976034 · P24-01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗